Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2026-03-09 @ 9:56 AM
Study NCT ID:
NCT02283606
Status:
UNKNOWN
Last Update Posted:
2015-09-23
First Post:
2014-10-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonoelastography of the Uterine Cervix Before Induction of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2014-10-26', 'studyFirstSubmitQcDate': '2014-11-01', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elasticity of the uterine cervix as measured sonoelastographically in successful and failed inductions of labor', 'timeFrame': '48-72 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'descriptionModule': {'briefSummary': 'The investigators aim to measure sonoelastographically the elasticity of the uterine cervix in pregnant patients at term before induction of labor and compare between patients with successful and failed inductions.', 'detailedDescription': "Softening of the uterine cervix in pregnant patients at term causes changes in its elasticity.these changes may affect success or failure in induction of labor.The elasticity of the uterine cervix is usually evaluated clinically and subjectively by vaginal examination (bishop's score) which is not very predictive.We aim to measure the elasticity quantitatively and objectively.The difference in strain, in the area of the internal os , is often illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.The color maps will be compared between patients with successful and failed inductions."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20-44 years old pregnant patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant patients before induction of labor\n\nExclusion Criteria:\n\n* pregnant patients undergoing caesaren section following induction of labor not in active labor'}, 'identificationModule': {'nctId': 'NCT02283606', 'acronym': 'SUCI', 'briefTitle': 'Sonoelastography of the Uterine Cervix Before Induction of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Meir Medical Center'}, 'officialTitle': 'Sonoelastography of the Uterine Cervix Before Induction of Labor', 'orgStudyIdInfo': {'id': '0154-14-MMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Accuvix SnonAce UGEO', 'type': 'DEVICE', 'description': 'vaginal ultrasonography'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rami Aviram', 'role': 'CONTACT', 'email': 'rami.aviram@clalit.org.il', 'phone': '972544944862'}], 'overallOfficials': [{'name': 'Rami Aviram, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Meir Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Meir Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Rami Aviram', 'investigatorAffiliation': 'Meir Medical Center'}}}}